Lokelma

/ Astra Zeneca

Correction phase
The recommended starting dose is 10 g, administered three times a day orally as a suspension in water.
If patients are still hyperkalaemic after 48 hours of treatment, the same regimen can be continued for an additional 24 hours. If normokalaemia is not achieved after 72 hours of treatment, other treatment approaches should be considered.
Maintenance phase
When normokalaemia has been achieved, the minimal effective dose to prevent recurrence of hyperkalaemia should be established. A starting dose of 5 g once daily is recommended, with possible titration up to 10 g once daily, or down to 5 g once every other day, as needed, to maintain a normal potassium level. No more than 10 g once daily should be used for maintenance therapy.
See prescribing information for full details.

Treatment of hyperkalaemia in adult patients

Hypersensitivity to the active substance

Serum potassium levels
Serum potassium should be monitored when clinically indicated, including after changes are made to medicinal products that affect the serum potassium concentration (e.g. renin-angiotensin-aldosterone system (RAAS) inhibitors or diuretics) and after the this medical product is titrated.
Monitoring frequency will depend upon a variety of factors including other medicinal products, progression of chronic kidney disease and dietary potassium intake.
Hypokalaemia
Dose titration as described under maintenance posology may be required in such cases to prevent moderate to severe hypokalaemia. In patients with severe hypokalaemia, this medical product should be discontinued and the patient re-evaluated.
Worsening of pre-existing heart failure
Patients with pre-existing heart failure, particularly those in whom an increased sodium intake may lead to fluid overload and decompensation, should be monitored for manifestations of worsening heart failure. These may include increased dyspnoea, oedema and rapid weight gain, and should be managed as per standard clinical practice.
QT Prolongation
During correction of hyperkalaemia, a lengthening of the QT interval can be observed as the physiologic result of a decline in serum potassium concentration.
The risk of interaction with X-rays
Risk of interaction with X-rays Sodium zirconium cyclosilicate may be opaque to X-rays. If the patient is undergoing an abdominal X-ray, the relevant medical team should be informed that the drug is being taken.
See prescribing information for full details.

Very Common: Worsening of pre-existing heart failure
Common: Hypokalaemia, Constipation, Oedema related events
See prescribing information for full details.

Effect of other medicinal products on sodium zirconium cyclosilicate
As sodium zirconium cyclosilicate is not absorbed or metabolised by the body, there are no expected effects of other medicinal products on the pharmacologic action of sodium zirconium cyclosilicate.
Effect of sodium zirconium cyclosilicate on other medicinal products
As sodium zirconium cyclosilicate is not absorbed or metabolised by the body, and does not meaningfully bind other medicinal products, there are limited effects on other medicinal products.
Sodium zirconium cyclosilicate can transiently increase gastric pH by absorbing hydrogen ions and can lead to changes in solubility and absorption kinetics for co-administered medicinal products with pH-dependent bioavailability.
Sodium zirconium cyclosilicate should be administered at least
2 hours before or 2 hours after oral medicinal products with clinically meaningful gastric pH dependent bioavailability. Sodium zirconium cyclosilicate can be co-administered without spacing of dosing times with oral medicinal products that do not exhibit pH-dependent bioavailability.
See prescribing information for full details.

Pregnancy: There are no data from the use of sodium zirconium cyclosilicate in pregnant women. As a precautionary measure, it is preferable to avoid the use during pregnancy.
Lactation: Due to its physicochemical properties, sodium zirconium cyclosilicate is not systemically absorbed and is not expected to be excreted in breast milk. No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to sodium zirconium cyclosilicate is negligible. This medical product can be used during breast-feeding.

Overdose with sodium zirconium cyclosilicate could lead to hypokalaemia. Serum potassium should be checked and potassium supplemented as needed.